Pennsaid

Horizon Therapeutics USA, Inc.🇺🇸 United States

FDA Page

Effective Date: Nov 28, 2025
Approval ID: 802cd382-443d-48e3-9c9d-fd946c73c79f
Products: 1 registered
Version: 12

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use PENNSAID safely and effectively. See full prescribing information for PENNSAID. PENNSAID (diclofenac sodium) topical solution 2% w/w, for topical use Initial U.S. Approval: 1988

Quick Stats

Total Products1

Labelers2

Label Sections43

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.